Nitrocamptothecin in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

NCT00005873 | Completed Phase 2

• 3 other identifiers: CDR0000067909SUPERGEN-RFS2000-17IUMC-9906-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

rubitecan DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally recurrent or metastatic breast cancer not amenable to surgery or radiotherapy Measurable or evaluable disease No prior radiotherapy to only target lesion Disease progression after no more than 2 prior chemotherapy treatments for metastatic disease No active CNS metastasis Prior CNS metastasis allowed with no evidence of active disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Hemoglobin greater than 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to have daily fluid intake of at least 3 liters No concurrent active infection No other prior malignancy in past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan, topotecan, or other camptothecin analogues At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids to control CNS disease Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (1)

SuperGen, Incorporated

Dublin, California, 94568, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Show-Li Sun, MD

  Astex Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: April 13, 2004
• Study Start: September 1, 1999
• Study Completion: April 1, 2004
• Last Updated: December 4, 2013

Record last verified: 2001-09

Locations

US (1)